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Schedule for generic substitution and the reference price system

Abbreviations used in the table

  • Fimea = Finnish Medicines Agency
  • Hila = Pharmaceuticals Pricing Board
  • Kela = Social Insurance Institution of Finland
Schedule for generic substitution and the reference price system
Timetable2nd
quarter
2024
3rd
quarter
2024
4th
quarter
2024
1st
quarter
2025
Fimea publishes a list of substitutable products at the latest by15.2.202416.5.202416.8.202415.11.2024
The pharmaceutical companies report corrections and additions to Fimea at the latest by22.2.202423.5.202423.8.202422.11.2024
Fimea publishes the updated list23.2.202424.5.202426.8.202425.11.2024
Hila publishes a list of products subject to the price notification procedure at the latest by1.3.202431.5.202430.8.202429.11.2024
Price notifications of the pharmaceutical companies to Kela at the latest by8.3.2024
at 16:15
7.6.2024
at 16:15
9.9.2024
at 16:15
10.12.2024
at 16:15
E-service for pharmaceutical companies open*1.3–
8.3.2024
31.5–
7.6.2024
30.8–
9.9.2024
29.11–
10.12.2024
Hila publishes a decision on the reference prices and Kela publishes the price bands at the latest by22.3.202420.6.202423.9.202423.12.2024

* The service can only be used by pharmaceutical companies that have a Finnish business ID (Y-tunnus). The service is only available in Finnish and Swedish.

The schedule is based on the following legal provisions:

  • Fimea must publish a list of interchangeable products at the latest 45 days before the beginning of each quarter (Medicines Act, chapter 6, section 57c, subsection 2).
  • Hila must publish a list of the products subject to the price notification procedure at the latest 30 days before the start of the reference price period (Health Insurance Act, chapter 6, section 20, subsection 1).
  • Prices for interchangeable medicines must be notified to Kela at least 21 days before the first day of each quarter. Kela forwards the price notifications to Hila for determination of the reference prices (Decree of the Ministry of Social Affairs and Health concerning generic substitution, section 1, subsection 1).
  • The marketing authorisation holder must notify the wholesale price of a product subject to the price notification procedure to Hila at the latest 21 days before the start of the reference price period (Health Insurance Act, chapter 6, section 20, subsection 2).
  • Hila must make a decision on the reference price groups, the reference prices and the inclusion of a product in the reference price group at the latest seven days before the start of the reference price period (Health Insurance Act, chapter 6, section 21, subsection 2).
  • Kela must publish a list of the interchangeable products notified to Kela and their prices at the latest seven days before the first day of each quarter (Decree of the Ministry of Social Affairs and Health concerning generic substitution, section 1, subsection 2).

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Last modified 6/2/2024

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